G-BA says Adcetris has 'unquantifiable' additional benefit
Germany's Federal Joint Committee (G-BA) said in a final assessment that lymphoma drug Adcetris brentuximab vedotin from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) has an "unquantifiable" degree of additional benefit. Adcetris has conditional approval from the European Commission to treat relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) and for relapsed or refractory CD30-positive Hodgkin's lymphoma. Takeda will now negotiate a price for the Orphan drug with Germany's Statutory Health Insurance Funds Association (GKV-Spitzenverband).
Under drug pricing law AMNOG, the additional benefit of Orphan products is regarded as having been demonstrated by the marketing authorization. Orphan products with an annual cost of less than EUR 50 million to the German statutory health insurance funds (GKV) do not undergo a formal benefit assessment through the Institute for Quality and Efficiency in Health Care (IQWiG), though G-BA still determines the extent of the additional benefit based on a product's marketing authorization studies. ...